Ketoconazole Dosage

This dosage information may not include all the information needed to use Ketoconazole safely and effectively. See additional information for Ketoconazole.

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Blastomycosis

Initial dose: 200 mg orally once a day
If clinical responsiveness insufficient within expected time: Dose may be increased to 400 mg orally once a day.
Duration of therapy: 6 months (usual duration for systemic infection)

Comments:
-Use of ketoconazole is only recommended when other effective antifungal therapy is not available or tolerated and the benefits outweigh the risks.
-Ketoconazole should not be used for fungal meningitis (penetrates poorly into CSF).
-The Infectious Diseases Society of America (IDSA) guidelines recommend amphotericin B and itraconazole as preferred therapies for blastomycosis and histoplasmosis.

Approved indications: For treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, paracoccidioidomycosis

Usual Adult Dose for Chromomycosis

Initial dose: 200 mg orally once a day
If clinical responsiveness insufficient within expected time: Dose may be increased to 400 mg orally once a day.
Duration of therapy: 6 months (usual duration for systemic infection)

Comments:
-Use of ketoconazole is only recommended when other effective antifungal therapy is not available or tolerated and the benefits outweigh the risks.
-Ketoconazole should not be used for fungal meningitis (penetrates poorly into CSF).
-The Infectious Diseases Society of America (IDSA) guidelines recommend amphotericin B and itraconazole as preferred therapies for blastomycosis and histoplasmosis.

Approved indications: For treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, paracoccidioidomycosis

Usual Adult Dose for Coccidioidomycosis

Initial dose: 200 mg orally once a day
If clinical responsiveness insufficient within expected time: Dose may be increased to 400 mg orally once a day.
Duration of therapy: 6 months (usual duration for systemic infection)

Comments:
-Use of ketoconazole is only recommended when other effective antifungal therapy is not available or tolerated and the benefits outweigh the risks.
-Ketoconazole should not be used for fungal meningitis (penetrates poorly into CSF).
-The Infectious Diseases Society of America (IDSA) guidelines recommend amphotericin B and itraconazole as preferred therapies for blastomycosis and histoplasmosis.

Approved indications: For treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, paracoccidioidomycosis

Usual Adult Dose for Histoplasmosis

Initial dose: 200 mg orally once a day
If clinical responsiveness insufficient within expected time: Dose may be increased to 400 mg orally once a day.
Duration of therapy: 6 months (usual duration for systemic infection)

Comments:
-Use of ketoconazole is only recommended when other effective antifungal therapy is not available or tolerated and the benefits outweigh the risks.
-Ketoconazole should not be used for fungal meningitis (penetrates poorly into CSF).
-The Infectious Diseases Society of America (IDSA) guidelines recommend amphotericin B and itraconazole as preferred therapies for blastomycosis and histoplasmosis.

Approved indications: For treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, paracoccidioidomycosis

Usual Adult Dose for Paracoccidioidomycosis

Initial dose: 200 mg orally once a day
If clinical responsiveness insufficient within expected time: Dose may be increased to 400 mg orally once a day.
Duration of therapy: 6 months (usual duration for systemic infection)

Comments:
-Use of ketoconazole is only recommended when other effective antifungal therapy is not available or tolerated and the benefits outweigh the risks.
-Ketoconazole should not be used for fungal meningitis (penetrates poorly into CSF).
-The Infectious Diseases Society of America (IDSA) guidelines recommend amphotericin B and itraconazole as preferred therapies for blastomycosis and histoplasmosis.

Approved indications: For treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, paracoccidioidomycosis

Usual Pediatric Dose for Blastomycosis

2 years or older: 3.3 to 6.6 mg/kg orally once a day
Duration of therapy: 6 months (usual duration for systemic infection)

Comments:
-Ketoconazole should not be used unless the benefit outweighs the risks.
-Ketoconazole should not be used for fungal meningitis (penetrates poorly into CSF).
-The IDSA guidelines recommend amphotericin B and itraconazole as preferred therapies for blastomycosis and histoplasmosis.

Approved indications: For treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, paracoccidioidomycosis

Usual Pediatric Dose for Chromomycosis

2 years or older: 3.3 to 6.6 mg/kg orally once a day
Duration of therapy: 6 months (usual duration for systemic infection)

Comments:
-Ketoconazole should not be used unless the benefit outweighs the risks.
-Ketoconazole should not be used for fungal meningitis (penetrates poorly into CSF).
-The IDSA guidelines recommend amphotericin B and itraconazole as preferred therapies for blastomycosis and histoplasmosis.

Approved indications: For treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, paracoccidioidomycosis

Usual Pediatric Dose for Coccidioidomycosis

2 years or older: 3.3 to 6.6 mg/kg orally once a day
Duration of therapy: 6 months (usual duration for systemic infection)

Comments:
-Ketoconazole should not be used unless the benefit outweighs the risks.
-Ketoconazole should not be used for fungal meningitis (penetrates poorly into CSF).
-The IDSA guidelines recommend amphotericin B and itraconazole as preferred therapies for blastomycosis and histoplasmosis.

Approved indications: For treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, paracoccidioidomycosis

Usual Pediatric Dose for Histoplasmosis

2 years or older: 3.3 to 6.6 mg/kg orally once a day
Duration of therapy: 6 months (usual duration for systemic infection)

Comments:
-Ketoconazole should not be used unless the benefit outweighs the risks.
-Ketoconazole should not be used for fungal meningitis (penetrates poorly into CSF).
-The IDSA guidelines recommend amphotericin B and itraconazole as preferred therapies for blastomycosis and histoplasmosis.

Approved indications: For treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, paracoccidioidomycosis

Usual Pediatric Dose for Paracoccidioidomycosis

2 years or older: 3.3 to 6.6 mg/kg orally once a day
Duration of therapy: 6 months (usual duration for systemic infection)

Comments:
-Ketoconazole should not be used unless the benefit outweighs the risks.
-Ketoconazole should not be used for fungal meningitis (penetrates poorly into CSF).
-The IDSA guidelines recommend amphotericin B and itraconazole as preferred therapies for blastomycosis and histoplasmosis.

Approved indications: For treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, paracoccidioidomycosis

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Acute or chronic liver disease: Contraindicated

If ALT increases to above upper limit of normal (ULN) or 30% above baseline, or if symptoms of liver injury develop: Interrupt therapy.

Precautions

Consult WARNINGS section for dosing related precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-Ketoconazole requires acidity for dissolution and absorption; absorption impaired when gastric acid production is reduced.

Storage requirements:
-Should protect from moisture

General:
-There should be laboratory as well as clinical documentation of infection before starting ketoconazole therapy.
-Therapy should continue until active fungal infection has subsided.

Monitoring:
-Endocrine: Adrenal function in patients with adrenal insufficiency, with borderline adrenal function, or under prolonged periods of stress (e.g., major surgery, intensive care)
-Hematologic: Laboratory tests such as prothrombin time, INR (at baseline)
-Hepatic: Laboratory tests such as serum GGT, alkaline phosphatase, ALT, AST, total bilirubin (at baseline); testing for viral hepatitides (at baseline); serum ALT (weekly during therapy); full set of liver tests (if ALT increases to above ULN or 30% above baseline, or if symptoms of liver injury develop); recurring liver injury (frequently if drug restarted after interruption due to increased ALT or symptoms of liver injury)

Patient advice:
-Report any signs/symptoms suggesting liver dysfunction (including unusual fatigue, anorexia, nausea and/or vomiting, abdominal pain, jaundice, dark urine, pale stools).
-Do not consume alcohol during therapy.

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